Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial (CABANA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Mayo Clinic
Sponsor:
Collaborators:
St. Jude Medical
Biosense Webster, Inc.
Information provided by (Responsible Party):
Douglas L. Packer, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00911508
First received: May 28, 2009
Last updated: January 20, 2014
Last verified: January 2014
  Purpose

The (Catheter Ablation Versus Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial) CABANA Trial has the overall goal of establishing the appropriate roles for medical and ablative intervention for atrial fibrillation (AF). The CABANA Trial is designed to test the hypothesis that the treatment strategy of left atrial catheter ablation for the purpose of eliminating atrial fibrillation (AF) will be superior to current state-of-the-art therapy with either rate control or rhythm control drugs for decreasing the incidence of the composite endpoint of total mortality, disabling stroke, serious bleeding, or cardiac arrest in patients with untreated or incompletely treated AF.


Condition Intervention
Atrial Fibrillation
Arrhythmia
Device: Left atrial ablation
Drug: Rate or Rhythm Control Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • LA catheter ablation is superior to rate or rhythm control drug therapy for decreasing the incidence of the composite endpoint of total mortality, disabling stroke, serious bleeding, or cardiac arrest in patients warranting therapy for AF. [ Time Frame: From date of enrollment until date of event ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • LA catheter ablation is superior to rate or rhythm control drug therapy for reducing total mortality [ Time Frame: From date of enrollment until date of death ] [ Designated as safety issue: Yes ]
  • Total mortality or cardiovascular hospitalization [ Time Frame: From date of enrollment until date of death or CV hospitalization ] [ Designated as safety issue: Yes ]
  • Cardiovascular death [ Time Frame: From date of enrollment until date of death ] [ Designated as safety issue: Yes ]
  • Cardiovascular death or disabling stroke [ Time Frame: From date of enrollment until date of event ] [ Designated as safety issue: Yes ]
  • Arrhythmic death or cardiac arrest [ Time Frame: From date of enrollment until date of event ] [ Designated as safety issue: Yes ]
  • Heart failure death [ Time Frame: From date of enrollment until date of event ] [ Designated as safety issue: Yes ]
  • Freedom from recurrent AF [ Time Frame: From date of therapy initiation until date of first AF recurrence following a 90 day wait period ] [ Designated as safety issue: No ]
  • Cardiovascular hospitalization [ Time Frame: From date of enrollment until date of hospitalization ] [ Designated as safety issue: Yes ]
  • Medical costs, resource utilization, and cost effectiveness [ Time Frame: From date of enrollment through follow-up (average of 5 years) ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: At months 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 ] [ Designated as safety issue: No ]
  • Composite adverse events [ Time Frame: From date of enrollment until date of event ] [ Designated as safety issue: Yes ]
  • Left atrial size, morphology and function and its relationship to morbidity and mortality [ Time Frame: Baseline compared with 3-6 months post therapy initiation ] [ Designated as safety issue: No ]

Estimated Enrollment: 2200
Study Start Date: August 2009
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Left Atrial Ablation
Pulmonary vein isolation using a circumferential ablative approach in the left atrium. Ablation may be performed using circular mapping catheter-guided ablation, antral isolation using a circular guided approach, or wide area circumferential ablation.
Device: Left atrial ablation

St. Jude: Livewire TC™ , Therapy™ Dual / Thermocouple, Safire,Therapy Cool Path

Biosense Webster: NAVI-STAR, NAVI-STAR/NAVI-STAR DS, Celsius Braided/Long Tip, NAVI-STAR™ and Celsius™ ThermoCool, NAVI-STAR® RMT, Celsius® RMT, ThermoCool® SF

Medtronic CryoCath LP: Freezor®/Freezor MAX®, Artic Front®, Cardiac Ablation System

Bard: Stinger

Boston Scientific: Blazer II RF/XP, Blazer RPM, Chilli II Cooled, SteeroCath

Active Comparator: Rate or Rhythm Control Therapy
Current state-of-the-art drug therapy for atrial fibrillation (rate control or rhythm control). Treating physicians will be encouraged to follow the American College of Cardiology / American Heart Association / European Society of Cardiology Atrial Fibrillation Guidelines with regard to drug therapy for atrial fibrillation. The specific choice of rate control versus rhythm control drug therapy and the specific drugs to be used will ultimately be left to the discretion of the treating physician.
Drug: Rate or Rhythm Control Therapy

Rate control: Metoprolol 50-100mg, Atenolol 50-100mg, Propranolol 40-80mg, Acebutolol 200-300mg, Carvedilol 6.25-25mg, Diltiazem 180-240mg, Verapamil 180-240mg, Digoxin 0.125-0.25mg

Rhythm control: Propafenone 450-625mg, Flecainide 200-300mg, Sotalol 240-320mg, Dofetilide 500-1000mcg, Amiodarone 200-400mg, Quinidine 600-900mg, Dronedarone 800mg


Detailed Description:

The need for this trial arises out of 1) the rapidly increasing number of pts > 60 years of age with AF accompanied by symptoms and morbidity, 2) the failure of anti-arrhythmic drug therapy to maintain sinus rhythm and reduce mortality, 3) the rapidly increasing application of radio-frequency catheter ablation without appropriate evidence-based validation, and 4) the expanding impact of AF on health care costs.

This study will randomize up to 2200 patients to a strategy of catheter ablation versus pharmacologic therapy with rate or rhythm control drugs. Each pt will have 1) characteristics similar to AFFIRM pts (≥65 yo or <65 with >1 risk factor for stroke, 2) Documented AF warranting treatment, and 3) Eligibility for both catheter ablation and ≥2 anti-arrhythmic or ≥2 rate control drugs. Pts will be followed every 6 months for an average of approximately 5 years and will undergo repeat trans-telephonic monitor, Holter monitor, and CT/MR studies to assess the impact of treatment.

The CABANA trial will disclose the role of medical and non-pharmacologic therapies for AF, establish the cost and impact of therapy on quality of life and will help determine if AF is a modifiable risk factor for increased mortality.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Over the preceding 6 months have:

    1. ≥2 paroxysmal (electrocardiographic documentation of at least 1) AF episodes lasting ≥1 hour in duration: (that terminate spontaneously within 7 days or cardioversion is performed within 48h of AF onset): or
    2. electrocardiographic documentation of 1 persistent AF episode: (sustained for ≥7 days or cardioversion is performed more than 48h after AF onset): or
    3. electrocardiographic documentation of 1 longstanding persistent AF episode: (continuous AF of duration >1 year).
  • Warrant active therapy (within the past 3 months) beyond simple ongoing observation
  • Be eligible for catheter ablation and ≥2 sequential rhythm control and/or ≥2 rate control drugs.
  • Be ≥65 yrs of age, or <65 yrs with one or more of the following risk factors for stroke: Hypertension (treated and/or defined as a BP >140/90 mmHg) [90], Diabetes (treated and/or defined as a fasting glucose ≥126 mg/dl) [91], Congestive heart failure (including systolic or diastolic heart failure), Prior stroke, TIA or systemic emboli, Atherosclerotic vascular disease (previous MI, peripheral arterial disease or aortic plaque), LA size >5.0 cm (or volume index ≥40 cc/m2), or EF ≤35.
  • Have the capacity to understand and sign an informed consent form.
  • Be ≥18 years of age.

    • NOTE- Subjects <65 yrs of age whose only risk factor is hypertension must have a second risk factor or LV hypertrophy to qualify.Patients receiving new drug therapy initiated within the previous 3 months may continue that therapy if randomized to the drug therapy arm. Patients may have documented atrial flutter in addition to atrial fibrillation and remain eligible for enrollment.

Exclusion Criteria:

  • Lone AF in the absence of risk factors for stroke in patients <65 years of age
  • Patients who in the opinion of the managing clinician should not yet receive any therapy for AF
  • Patients who have failed >2 membrane active anti-arrhythmic drugs at a therapeutic dose due to inefficacy or side effects (Table 5.2.2)
  • An efficacy failure of full dose amiodarone treatment >8 weeks duration at any time
  • Reversible causes of AF including thyroid disorders, acute alcohol intoxication, recent major surgical procedures, or trauma
  • Recent cardiac events including MI, PCI, or valve or bypass surgery in the preceding 3 months
  • Hypertrophic obstructive cardiomyopathy (outflow track)
  • Class IV angina or Class IV CHF (including past or planned heart transplantation)
  • Other arrhythmias mandating anti-arrhythmic drug therapy (i.e. VT, VF)
  • Heritable arrhythmias or increased risk for torsade de pointes with class I or III drugs
  • Prior LA catheter ablation with the intention of treating AF
  • Prior surgical interventions for AF such as the MAZE procedure
  • Prior AV nodal ablation
  • Patients with other arrhythmias requiring ablative therapy
  • Contraindication to appropriate anti-coagulation therapy
  • Renal failure requiring dialysis
  • Medical conditions limiting expected survival to <1 year
  • Women of childbearing potential (unless post-menopausal or surgically sterile)
  • Participation in any other clinical mortality trial (Participation in other non-mortality trials should be reviewed with the clinical trial management center)
  • Unable to give informed consent

    • NOTE- Prior ablation of the cavo-tricuspid isthmus alone is not an exclusion if the patient develops subsequent recurrent AF. Planned atrial flutter ablation in combination with the left atrial ablation is not an exclusion.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00911508

Contacts
Contact: Kristi H. Monahan, RN, BS 507-255-6676 CABANA@mayo.edu
Contact: Mona Branstad 507-538-4358 CABANA@mayo.edu

  Hide Study Locations
Locations
United States, Arizona
Scottsdale Healthcare Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Deandra O'Connor    480-323-3833    deoconnor@shc.org   
Principal Investigator: Andy Tran, M.D.         
United States, Arkansas
Arkansas Cardiology, PA Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Michael Seamon    501-227-7596    michael.seamon@arcard.org   
Principal Investigator: Gerald Greer, M.D.         
United States, California
Good Samaritan Hospital Recruiting
Los Angeles, California, United States, 90017
Contact: Young Park    213-977-4175    ypark@lacard.com   
Principal Investigator: Anil Bhandari, M.D.         
University of California Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Shelly Cote    310-206-2235    scote@mednet.ucla.edu   
Principal Investigator: Eric Buch, M.D.         
University of California Davis Medical Center Recruiting
Sacramento, California, United States, 95817
Contact: Margaret Norton    916-734-5671    margaret.norton@ucdmc.ucdavis.edu   
Principal Investigator: Nayer Pezeshkian, M.D.         
University of California at San Francisco Medical Center Recruiting
San Francisco, California, United States, 94143
Contact: Jameze James    415-476-9128    jjames@medicine.ucsf.edu   
Principal Investigator: Nitish Badhwar, M.D.         
Stanford University Medical Center Recruiting
Stanford, California, United States, 94305
Contact: Carlene Lugtu    650-723-7111    clugtu@stanfordmed.org   
Principal Investigator: Paul Zei, M.D.         
United States, Colorado
The Medical Center of Aurora Recruiting
Aurora, Colorado, United States, 80045
Contact: Deborah Dahler       deborah.dahler2@healthonecares.com   
Principal Investigator: Andrew Cohen, M.D.         
University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
Contact: Christina Schmitt    303-724-2098    christina.schmitt@ucdenver.edu   
Principal Investigator: Ryan Aleong, M.D.         
Penrose Saint Francis Health Services Recruiting
Colorado Springs, Colorado, United States, 80907
Contact: Susan Stoddard    719-634-6671    sstoddard@cscardiologists.com   
Principal Investigator: Christopher Cole, M.D.         
United States, Connecticut
Hartford Hospital Recruiting
Hartford, Connecticut, United States, 06115
Contact: Ellen Volponi    860-545-3416    evolponi@harthosp.org   
Principal Investigator: Eric Michael Crespo, M.D.         
United States, District of Columbia
Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Richard Quick    202-877-6152    richard.a.quick@medstar.net   
Principal Investigator: Zayd Eldadah, M.D.         
George Washington University Medical Faculty Associates Recruiting
Washington, D.C., District of Columbia, United States, 20037
Contact: Lorraine Marshall    202-741-2318    lmarshall@mfa.gwu.edu   
Principal Investigator: Cynthia Tracy, M.D.         
United States, Florida
University of Miami Hospital Recruiting
Miami, Florida, United States, 60612
Contact: Laura Hudson    305-243-5678    ljhudson@med.miami.edu   
Principal Investigator: Raul Mitrani, M.D.         
Florida Hospital Recruiting
Orlando, Florida, United States, 32803
Contact: Leann Goodwin    407-303-7556    leann.goodwin@flhosp.org   
Principal Investigator: George Monir, M.D.         
Bay Area Heart Center Recruiting
St. Petersburg, Florida, United States, 33709
Contact: Mary Finn    727-544-1441    mfinn@bahc.com   
Principal Investigator: Shalin Shah, M.D.         
Northside Hospital and Heart Institute Recruiting
St. Petersburg, Florida, United States, 33709
Contact: Heather Harteneck         
Principal Investigator: Robert Sheppard, MD         
Tallahassee Memorial Hospital Recruiting
Tallahassee, Florida, United States, 32308
Contact: Patty Knap    850-431-5024    patty.knap@tmh.org   
Principal Investigator: Farhat Khairallah, M.D.         
Florida Heart Rhythm-University of South Florida College of Medicine Recruiting
Tampa, Florida, United States, 33606
Contact: Rachel Karlnoski    813-844-4413    rkarlnos@hsc.usf.edu   
Principal Investigator: Bengt Herweg, M.D.         
United States, Georgia
Georgia Health Sciences University Recruiting
Augusta, Georgia, United States, 30912
Contact: Carol Smith    706-721-0193    csmith@georgiahealth.edu   
Contact: Brenda Rosson    1-706-721-0193    brosson@georgiahealth.edu   
Principal Investigator: Adam Berman, MD         
Georgia Arrhythmia Consultants & Research Institute Recruiting
Macon, Georgia, United States, 31201
Contact: Justin Johnson    478-755-1560    jjohnson@gacri.com   
Principal Investigator: Felix Sogade, MD         
United States, Illinois
Alexian Brothers Medical Center Recruiting
Barrington, Illinois, United States, 60010
Contact: Elaine Enger    844-427-7230    eenger@cvamd.com   
Principal Investigator: Mohammed N Khan, M.D.         
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Clare Tessman, SC       clare_tessman@rush.edu   
Principal Investigator: Kousik Krishnan, MD         
NorthShore University Health System Recruiting
Evanston, Illinois, United States, 60201
Contact: Kathleen Medica    847-570-1997    kmedica@northshore.org   
Principal Investigator: Westby Fisher, M.D.         
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Jean Del Priori, RN    708-216-2644    jdelpri@lumc.edu   
Principal Investigator: David Wilber, M.D.         
United States, Iowa
Mercy Medical Center-Iowa Heart Center Active, not recruiting
West Des Moines, Iowa, United States, 50226
United States, Louisiana
Louisiana State University Health Science Center Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Cris Molina    504-568-2349    cmoli1@lsuhsc.edu   
Principal Investigator: Paul LeLorier, M.D.         
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Michele Martucci    410-502-0517    mmill148@jhmi.edu   
Principal Investigator: Hugh Calkins, M.D.         
United States, Massachusetts
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Tracey Lavey, SC       tracey.lavey@bmc.org   
Principal Investigator: Kevin Monahan, M.D.         
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Mai Doan       mdoan@mgh.harvard.edu   
Principal Investigator: Moussa Mansour, M.D.         
Brigham and Womens Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Christine Pellegrini, MSN    617-732-5241    cpellegrini@partners.org   
Principal Investigator: Gregory Michaud, M.D.         
United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Sandy Alexander    313-916-3766    salexan4@hfhs.org   
Principal Investigator: Claudio Schuger, M.D.         
Upper Michigan Cardiovascular Associates, PC Recruiting
Marquette, Michigan, United States, 49855
Contact: Jane Anderson    906-225-4733    jane.anderson@mghs.org   
Contact: Beth King    1-906-225-7663    elizabeth.king@mghs.org   
Principal Investigator: Rudolph Evonich III, M.D.         
Saint Joseph Mercy Hospital Recruiting
Ypsilanti, Michigan, United States, 48197
Contact: Gail Brandt    734-712-8386    gbrandt@michiganheart.com   
Principal Investigator: James Kappler, M.D.         
United States, Minnesota
Minneapolis V.A. Medical Center Recruiting
Minneapolis, Minnesota, United States, 55417
Contact: Kara Drekonja    612-467-3666    kara.drekonja@va.gov   
Principal Investigator: Venkat Tholakanahalli, MD         
Mayo Clinic Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: HRS Research Office    507-255-7456    peterson.laura@mayo.edu   
Principal Investigator: Douglas L. Packer, M.D.         
Sub-Investigator: David Bradley, M.D.         
Park Nicollet Methodist Hospital Recruiting
St. Louis Park, Minnesota, United States, 55426
Contact: Lorene Brown    952-993-3982    lorene.brown@parknicollet.com   
Principal Investigator: Jay Simonson, M.D.         
United States, Mississippi
Jackson Heart Clinic Recruiting
Jackson, Mississippi, United States, 39216
Contact: Janet Humphreys    601-982-7850 ext 271    jhumphreys@jacksonheart.com   
Principal Investigator: Byron Colley III, M.D.         
United States, Missouri
Saint John's Mercy Heart Health Center Recruiting
St. Louis, Missouri, United States, 63131
Contact: Judith Bagby       judith.bagby@mercy.net   
Principal Investigator: Jose Sanchez, M.D.         
Sub-Investigator: Stephen Pieper, MD         
Saint Louis Heart and Vascular Recruiting
St. Louis, Missouri, United States, 63136
Contact: Linda Bedsworth    314-741-0911 ext 4019    lbedsworth@slhv.com   
Principal Investigator: Saulius Kalvaitis, M.D.         
United States, New Jersey
Cooper University Hospital Recruiting
Camden, New Jersey, United States, 08103
Contact: Julie Field    856-669-8847    field-julie@cooperhealth.edu   
Principal Investigator: Andrea Russo, M.D.         
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Susan Mathus    201-996-5722    smathus@humed.com   
Principal Investigator: John Zimmerman, MD         
Robert Wood Johnson University Hospital Recruiting
News Brunswick, New Jersey, United States, 08901
Contact: Tosha Patel       patelts@rwjms.rutgers.edu   
Principal Investigator: James Coromilas, M.D.         
The Valley Hospital Recruiting
Ridgewood, New Jersey, United States, 07450-2736
Contact: DeAnna Kearney    201-447-8000 ext 2984    dkearne@valleyhealth.com   
Principal Investigator: Mark Preminger, M.D.         
United States, New York
Albany Associates in Cardiology Recruiting
Albany, New York, United States, 12205
Contact: Amy Sheldon    518-435-2758    amy.sheldon@primecarepc.com   
Principal Investigator: Guillermo E Sosa-Suarez, FACC         
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Dalena Hervias, SC    718-920-5733    dahervia@montefiore.org   
Principal Investigator: Eugen Palma, MD         
New York University Langone Medical Center Recruiting
New York, New York, United States, 10016
Contact: Laura Kuznekoff    212-263-7704    llaura.kuznekoff@nyumc.org   
Principal Investigator: Larry Chinitz, M.D.         
Stony Brook University Hospital and Medical Center Recruiting
Stony Brook, New York, United States, 11794-8167
Contact: Jennifer Intravaia       jennifer.intravaia@sbumed.org   
Principal Investigator: Eric Rashba, MD         
United States, North Carolina
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Cassandra Ramm    919-843-1610    cassandra_ramm@med.unc.edu   
Principal Investigator: Paul Mounsey, M.D.         
The Sanger Clinic, PA Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Connie Dellinger    704-355-4794    connie.dellinger@carolinashealthcare.org   
Principal Investigator: John Holshouser, M.D.         
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27705
Contact: Deborah Hickey    919-668-3524    deborah.hickey@duke.edu   
Principal Investigator: Tristram Bahnson, M.D.         
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Nancy Sherill    336-716-5865    nsheril@wfubmc.edu   
Principal Investigator: Tony Simmons, M.D.         
United States, Ohio
University of Cincinnati Medical Center Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Cindy Werner    513-558-1331    wernercy@ucmail.uc.edu   
Principal Investigator: Alexandru Costea, MD         
Medisync Recruiting
Cincinnati, Ohio, United States, 45429
Contact: Amanda Kincaid    937-312-8104    amanda.kincaid@primedphysicians.com   
Principal Investigator: Khawaja Baig, M.D.         
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44193
Contact: Raquel Rozich       rozichr@ccf.org   
Principal Investigator: Bruce Lindsay, M.D.         
Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Jennifer Bremer, BSN    614-293-4967    jennifer.bremer@osumc.edu   
Principal Investigator: John Hummel, M.D.         
University of Toledo Recruiting
Toledo, Ohio, United States, 43614
Contact: Christina Eisenhauer    419-383-3853    christina.eisenhauer@utoledo.edu   
Principal Investigator: Jennifer Cummings, M.D.         
United States, Oklahoma
Oklahoma Heart Institute Recruiting
Tulsa, Oklahoma, United States, 74104
Contact: Jolene Durham    918-579-4939    jdurham@hillcrest.com   
Principal Investigator: Craig Cameron, MD         
United States, Oregon
Providence Saint Vincent Medical Center Recruiting
Portland, Oregon, United States, 97225
Contact: Heather Aiona    503-216-2099    heather.aiona@providence.org   
Principal Investigator: Blair Halperin, M.D.         
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97201
Contact: Elizabeth Cannard    503-494-5893    cannarde@ohsu.edu   
Principal Investigator: Jack Kron, M.D.         
United States, Pennsylvania
Geisinger Wyoming Valley Medical Center Recruiting
Danville, Pennsylvania, United States, 17822-2160
Contact: Marilee Manganiello       mfmanganiello@geisinger.edu   
Principal Investigator: Pugazhendi Vijayaraman, MD         
Penn State University Cardiovascular Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Dena Jefferson    717-531-5967    djefferson1@hmc.psu.edu   
Principal Investigator: Mario Gonzalez         
University of Pennsylvania Health System Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Mary Gnap    215-349-8446    gnapm@uphs.upenn.edu   
Principal Investigator: Francis Marchlinski, M.D.         
Drexel University College of Medicine Recruiting
Philadelphia, Pennsylvania, United States, 19102
Contact: Christina Baessler    215-762-4641    cbaessle@drexelmed.edu   
Principal Investigator: S. Luke Kusmirek, M.D.         
V.A. Pittsburgh Healthcare System Recruiting
Pittsburgh, Pennsylvania, United States, 15240
Contact: Michael Seese       michael.seese@va.gov   
Principal Investigator: Alaa Shalaby, MD         
Lankenau Hospital Recruiting
Wynnewood, Pennsylvania, United States, 19096
Contact: Lisa Thome    484-476-8570    thomel@mlhs.org   
Principal Investigator: Steven Rothman, M.D.         
United States, South Carolina
Greenville Hospital System University Medical Center Recruiting
Greenville, South Carolina, United States, 29605
Contact: Erickia Channell    864-455-2288    echannell@ghs.org   
Sub-Investigator: Donald Rubenstein, M.D.         
United States, Tennessee
Memorial Health Care System Active, not recruiting
Chattanooga, Tennessee, United States, 37404
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Brenda White    615-936-2458    brenda.white@vanderbilt.edu   
Principal Investigator: Dawood Darbar, M.D.         
United States, Texas
Texas Cardiac Arrhythmia Recruiting
Austin, Texas, United States, 78705
Contact: Debbie Cardinal    512-458-9410    dscardinal@austinheartbeat.com   
Principal Investigator: Andrea Natale, M.D.         
Baylor Heart and Vascular Hospital Recruiting
Dallas, Texas, United States, 75226
Contact: Cathy Headley    214-820-3192    cathyhe@baylorhealth.edu   
Principal Investigator: Robert Kowal, M.D.         
Baylor All Saints Medical Center Recruiting
Fort Worth, Texas, United States, 76104
Contact: Deborah Devlin    817-922-2575    deborah.devlin@baylorhealth.edu   
Principal Investigator: John Jayachandran, MD         
University of Texas Health Science Center Active, not recruiting
Houston, Texas, United States, 77030
The Heart Hospital Baylor Plano Recruiting
Plano, Texas, United States, 75093
Contact: Gamar Rahimova    773-834-7081    gamar.rahimova@baylorhealth.edu   
Principal Investigator: J. Brian Deville, M.D.         
South Texas Cardiovascular Consultants Recruiting
San Antonio, Texas, United States, 78299
Contact: Jodie Addington       jaddington@heartdoctors.net   
Principal Investigator: Javier Roman-Gonzalez, MD         
Scott and White Memorial Hospital Recruiting
Temple, Texas, United States, 76508
Contact: Stephanie Blue    254-724-6750    slblue@swmail.sw.org   
Principal Investigator: Peter Cheung, MD         
United States, Utah
Intermountain Medical Center-LDS Hospital Recruiting
Salt Lake City, Utah, United States, 84143
Contact: Michael Malohifoou    801-507-4722    michael.malohifoou@imail.org   
Principal Investigator: Jared Bunch, M.D.         
United States, Virginia
University of Virginia Health System Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Mary Jane Strickland, sc    434-982-6401    mjs7w@virginia.edu   
Principal Investigator: James Mangrum, M.D.         
Virginia Hospital Center - Arlington Recruiting
Falls Church, Virginia, United States, 22042
Contact: Deanna Overbeck    703-766-5920    doverbeck@tcg.md   
Principal Investigator: Haroon Rashid, M.D.         
Sentara Norfolk General Hospital Recruiting
Norfolk, Virginia, United States, 23507
Contact: Linette Klevan       lrklevan@sentara.com   
Principal Investigator: Robert Bernstein, M.D.         
Virginia Commonwealth University Medical Center Recruiting
Richmond, Virginia, United States, 23219
Contact: Kim Kelly Hall    804-828-4565    khall@vcu.edu   
Principal Investigator: Kenneth Ellenbogen, M.D.         
United States, Washington
University of Washington Medical Center Recruiting
Seattle, Washington, United States, 98195
Contact: Michaela Galapon    206-221-5758    mgalapon@cardiology.washington.edu   
Principal Investigator: Mohan Viswanathan, MD         
Swedish Medical Center - Providence Campus Recruiting
Seattle, Washington, United States, 98122
Contact: Inger Rasmussen, SC    206-215-3989    inger.rasmussen@swedish.org   
Contact: Jenna Moody    1-206-215-2455    jenna.moody@swedish.org   
Principal Investigator: Darryl Wells, MD         
Cardiac Study Center Recruiting
Tacoma, Washington, United States, 98405
Contact: Meredith Barnhart    253-403-7258    meredith.barnhart@multicare.org   
Principal Investigator: Tariq Salam, MD         
United States, West Virginia
Saint Marys Hospital Recruiting
Huntington, West Virginia, United States, 25701
Contact: Cheryl Kane    304-526-8347    cheryl.kane@st-marys.org   
Principal Investigator: Aamir Cheema, M.D.         
United States, Wisconsin
Waukesha Memorial Hospital Recruiting
Waukesha, Wisconsin, United States, 53188
Contact: Katie Weis    262-928-7637    kathryn.weis@phci.org   
Principal Investigator: Vicken Vorperian, M.D.         
Australia, South Australia
Royal Adelaide Hospital Recruiting
Adelaide, South Australia, Australia, 5000
Contact: Karen Milburn    011-61-8-82222-2723    karen.milburn@adelaide.edu.au   
Principal Investigator: Prashanthan Sanders, MD         
Australia, Victoria
Royal Melbourne Hospital Recruiting
Parkville, Victoria, Australia, 3050
Contact: Karen Halloran    011-61-3-9342-8404    karen.halloran@mh.org.au   
Principal Investigator: Jonathan Kalman         
Canada, Alberta
University of Calgary Recruiting
Calgary, Alberta, Canada, T2N 2T9
Contact: Jennifer McKeage    403-210-6047    jmckeage@ucalgary.ca   
Principal Investigator: George Veenhuyzen         
Canada, Ontario
Hamilton Health Sciences Recruiting
Hamilton, Ontario, Canada, L8L 2X2
Contact: Victoria Malcolm    1-905-527-4322 ext 44506    malcolmv@hhsc.ca   
Principal Investigator: Carlos Morillo, M.D.         
University of Western Ontario - London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 5A5
Contact: Lindsay Hillock    1-519-685-8500 ext 34036    lindsay.hillock@lhsc.on.ca   
Principal Investigator: Allan Skanes, M.D.         
Southlake Regional Health Centre Recruiting
Newmarket, Ontario, Canada, L3Y 8C3
Contact: Sherri Patterson    1-905-895-4521    spatterson@southlakeregional.org   
Principal Investigator: Atul Verma, M.D.         
China, Guangdong
Guangdong Provincial People's Hospital Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Hongtao Liao    011-86-20-8382-7812    hometown1975@163.com   
Principal Investigator: Shulin Wu, MD         
China, Jiangsu
First Affiliated Hospital of Nanjing Medical University Recruiting
Nanjing, Jiangsu, China, 210029
Contact: Weizhu Ju    011-86-25-8378-1867    juweizhu@126.com   
Principal Investigator: Minglong Chen         
China, Liaoning
First Affiliated Hospital of Dalian Medical University Active, not recruiting
Dalian, Liaoning, China, 116011
China
Fuwai Hospital Recruiting
Beijing, China, 100037
Contact: Lihui Zheng       sunny_zlh2004@163.com   
Principal Investigator: Shu Zhang, Md         
Beijing Anzhen Hospital Recruiting
Beijing, China, 100029
Contact: Ribo Tang    011-86-010-6445-6372    tangribo1994@yahoo.com.cn   
Principal Investigator: Chang-Sheng Ma, M.D.         
Czech Republic
Na Homolce Hospital Recruiting
Prague 5, Hlavni Mesto Praha, Czech Republic, 150 30
Contact: Pavla Janotova    011-420-2-5727-3310    pavla.janotova@homolka.cz   
Principal Investigator: Petr Neuzil, M.D.         
Saint Anne's University Hospital, ICRC Recruiting
Brno, Czech Republic, 65691
Contact: Veronika Bulkova       veronika.bulkova@gmail.com   
Principal Investigator: Zdenek Starek, M.D.         
Charles University Recruiting
Prague 2, Czech Republic, 12808
Contact: Elen Eckertova       elen.eckertova@post.cz   
Contact: Stepan Havranek    011-420-224-962-219    stepan.havranek@centrum.cz   
Principal Investigator: Dan Wichterle, M.D.         
Clinic of Cardiology IKEM Medical Institute Recruiting
Prague 4, Czech Republic, 14021
Contact: Ivana Kamenarova    011-420-739-686-618    ivnm@ikem.cz   
Principal Investigator: Josef Kautzner, M.D.         
Germany
University Hospital of Mannheim Recruiting
Mannheim, Baden-Wurttemberg, Germany, 68167
Contact: Stefanie Dorn, SC    011-49-621-383-1493    stefanie.dorn@umm.de   
Principal Investigator: Martin Borggrefe, M.D.         
Klinikum Coburg Recruiting
Coburg, Bayern, Germany, 96450
Contact: Andrea Hoehn    011-49-9561-22-5381    andrea.hoehn@klinikum-coburg.de   
Principal Investigator: Johannes Brachmann         
Universitares Herrzentrum Hamburg Recruiting
Hamburg, Freie-Hansestadt Hamburg, Germany, 20246
Contact: Kathrin Heitmann    011-49-40-7410-59471    k.hietmann@uke.de   
Principal Investigator: Stephen Willems         
Herz-und Diabeteszentrum NRW Recruiting
Bad Oeynhausen, Nordrhein-Westfalen, Germany, D-32545
Contact: Simone Rolfsmeier    011-49-573-197-3545    srolfsmeier@hdz-nrw.de   
Principal Investigator: Georg Noelker, M.D.         
Kerckhoff Klinik Recruiting
Bad Nauheim, Germany, D-61231
Contact: Christine Scheld       c.scheld@kerckhoff-forschungs-gmbh.de   
Principal Investigator: Thomas Neumann         
Praxisklinik Herz and GefaBe Recruiting
Dresden, Germany, 01324
Contact: Kerstin Bonin, SC    011-49-351-8064-440    kerstin.bonin@zfkp-dresden.de   
Principal Investigator: Stefan Georg Spitzer         
CCB - Cardioaniologisches Centrum Bethanien Recruiting
Frankfurt, Germany, 60431
Contact: Ines Timmermanns, SC    011-49-69-9450-28272    i.timmermanns@ccb.de   
Principal Investigator: Julian Chun, MD         
Georg-August-University Recruiting
Gottingen, Germany, 37075
Contact: Margret Schwarz    011-49-551-391-0499    schwarz.ifs@med.uni-goettingen.de   
Principal Investigator: Markus Zabel, M.D.         
Asklepios Klinik St. Georg Recruiting
Hamburg, Germany, 20099
Contact: Erika Jacobsen    011-49-40-1818-853962    e.jacobsen@asklepios.com   
Contact: Claudia Kalkowski, SC       c.kalkowski@asklepios.com   
Principal Investigator: Karl-Heinz Kuck         
Asklepios Klinik Barmbek Recruiting
Hamburg, Germany, 22291
Contact: Thora Botschafter    011-49-40-181882-6317    t.botschafter@asklepios.com   
Principal Investigator: Gerian Groenefeld, M.D.         
Asklepios Klinik Barmbek Recruiting
Hamburg, Germany, 22291
Contact: Thora Botschafter, SC    011-49-40-181882-6317    t.botschafter@asklepios.com   
Principal Investigator: Gerian Groenefeld, MD         
Saint Vincentius-Kliniken Recruiting
Karlsruhe, Germany, 76137
Contact: Benjamin Rapp    011-49-721-8108-3177    benrapp@web.de   
Principal Investigator: Bernd-Dieter Gonska         
Herzzentrum Leipzig Recruiting
Leipzig, Germany, 04289
Contact: Daniela Guenther    49-314-865-1594    daniela.guenther@med.uni-leipzig.de   
Principal Investigator: Gerhard Hindricks         
Universitat Rostock Recruiting
Rostock, Germany, D-18057
Contact: Katharina Schlkopf       k.schoelkopf@web.de   
Principal Investigator: Dietmar Baensch, MD         
Italy
Policlinico San Donato Center of Clinical Arrhythmia and Electrophysiology Recruiting
San Donato Milanese, Lombardia, Italy, 20097
Contact: Cristina Balla       cristinaballa80@hotmail.com   
Principal Investigator: Riccardo Cappato, M.D.         
Azienda ospedaliera San Giovanni Battista di Torino Recruiting
Torino, Piedmont, Italy, 10126
Principal Investigator: Fiorenzo Gaita, M.D.         
Ospedale dell'Angelo Recruiting
Mestre, VE, Italy, 30174
Contact: Antonio Rossillo, M.D.    011-39-041-965-7201    antoniorossillo@yahoo.com   
Principal Investigator: Sakis Themistoclakis, M.D.         
Ospedale Cardinal Massaia Recruiting
Asti, Italy, 14100
Contact: Francesca Di Clemente, M.D.    011-39-141-487-121    diclementefrancesca@gmail.com   
Principal Investigator: Marco Scaglione, M.D.         
Maria Cecilia Hospital Active, not recruiting
Cotignola, Italy, 48010
Policlinico Multimedical Cardiology and Arrhythmia Centre Recruiting
Milan, Italy, 20099
Contact: Tiziana Staine       tiziana.staine@multimedica.it   
Principal Investigator: Annibale Montenero, M.D.         
Policlinico Casilino Recruiting
Rome, Italy, 00169
Contact: Alessio Borrelli, M.D.    011-390623188406    alessioborrelli@libro.it   
Principal Investigator: Leonardo Calo, M.D.         
Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Sul Hee Lee       suri1121@hanmail.net   
Principal Investigator: You-Ho Kim, MD         
Korea University Anam Hospital Recruiting
Seoul, Korea, Republic of
Contact: Oh Eun-Hye    011-82-2-920-6710    lydia1214@naver.com   
Principal Investigator: Young-Hoon Kim, MD         
Yonsei University Severance Hospital Recruiting
Soeul, Korea, Republic of
Contact: Mi-Hyang Park    011-82-2-2228-8528    pri-pri@yuhs.ac   
Principal Investigator: Hui-Nam Pak, MD         
Russian Federation
Research Institute of Circulation of Pathology Recruiting
Novosibirsk, Novosibirskaya Oblast, Russian Federation, 630055
Contact: Anastasia Sharygina, SC    011-7-9139-357-364    a_sharygina@nricp.ru   
Principal Investigator: Evgeny Pokushalov, MD         
Clinical Hospital # 83 under the Federal Medical and Biological Agency Recruiting
Moscow, Russian Federation, 115682
Contact: Evgeny Zhelyakov    011-7-49-539-506-78    zheleu@rambler.ru   
Principal Investigator: Andrey Ardashev, MD         
Bakoulev Scientific Center for Cardiovascular Surgery Recruiting
Moscow, Russian Federation, 121552
Principal Investigator: Amiran Revishvili, M.D.         
Scientific Research Institute of Cardiology of Ministry of Health of Russian Foundation Recruiting
Tomsk, Russian Federation, 634012
Contact: Roman Batalov       romancer@cardio.tsu.ru   
Principal Investigator: Sergey Popov, MD         
United Kingdom
Golden Jubilee Hospital Recruiting
Glasgow, United Kingdom, G81 4HX
Contact: Elizabeth Boyd    011-4401419515256    elizabeth.boyd@gjnh.scot.nhs.uk   
Principal Investigator: Derek Connelly, MD         
Saint Bartholomew's Hospital Recruiting
London, United Kingdom, EC1A 7BE
Contact: Ailsa McLean    011-44-20-7601-8639    ailsa.mclean@bartshealth.nhs.uk   
Principal Investigator: Richard Schilling, MD         
Saint George's Hospital Medical School Recruiting
London, United Kingdom, SW17 0QT
Contact: Kate Dougal       cdougal@sgul.ac.uk   
Principal Investigator: Mark Gallagher, MD         
Saint Mary's Hospital Recruiting
London, United Kingdom, W2 1NY
Contact: Michele Bianchi, SC       michele.bianchi@imperial.nhs.uk   
Contact: Andrew Copley, SC    011-44-20-7460-7400    a.copley@imperial.ac.uk   
Principal Investigator: David Davies, M.D.         
The Heart Hospital Recruiting
London, United Kingdom, W1G 8PH
Contact: Celina MFuko       celina.mfuko@uclh.nhs.uk   
Principal Investigator: Martin Lowe         
Sponsors and Collaborators
Mayo Clinic
St. Jude Medical
Biosense Webster, Inc.
Investigators
Principal Investigator: Douglas L. Packer, M.D. Mayo Clinic
Principal Investigator: Kerry L. Lee, Ph.D. Duke Clinical Research Institute
Principal Investigator: Daniel B. Mark, M.D., MPH Duke Clinical Research Institute
Principal Investigator: Rich A. Robb, Ph.D. Phy Mayo Clinic
Study Chair: Yves D. Rosenberg, M.D., MPH National Heart, Lung, and Blood Institute (NHLBI)
  More Information

Additional Information:
No publications provided

Responsible Party: Douglas L. Packer, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00911508     History of Changes
Other Study ID Numbers: 08-007043 09-004616, U01HL089709
Study First Received: May 28, 2009
Last Updated: January 20, 2014
Health Authority: United States: Food and Drug Administration
United States: Federal Government

Keywords provided by Mayo Clinic:
Atrial Fibrillation
Left Atrial Ablation
Pulmonary Vein Isolation
Catheter Ablation
Antiarrhythmic Drug Therapy

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Atrial Fibrillation
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 18, 2014